NovoSeven® in Severe Postpartum Haemorrhage - Experiences From UK, DK, FR, NL

Summary

The overall aim of this project is to include currently available information from women with severe postpartum haemorrhage (sPPH) who were treated with NovoSeven® and to examine whether NovoSeven® may have affected the course of the PPH in these women, specifically the control of bleeding. Data will be included from previous cohort studies from four countries: United Kingdom (UK), the Netherlands, Denmark, and France.

Conditions

• Post Partum Hemorrhage

Interventions

DRUG

Eptacog alfa

Recombinant coagulation factor VII activated

OTHER

Standard of care

Patients have been treated according to local routine clinical practice at the discretion of the treating physician.

Sponsors & Collaborators

• Novo Nordisk A/S

  collaborator INDUSTRY

• Herlev Hospital

  collaborator OTHER

• University of Oxford

  collaborator OTHER

• VU University of Amsterdam

  collaborator OTHER

• Leiden University Medical Center

  lead OTHER

Principal Investigators

• Johanna G van der Bom, MD, PhD · Leiden University Medical Center, Netherlands

• Hellen Edwards, MD, PhD · Herlev University Hospital, Denmark

• Catherine Deneux-Tharaux, MD, PhD · INSERM, France

• Marian Knight, MD, PhD · University of Oxford, UK

• Camilla Birkegård, PhD · Novo Nordisk A/S

• Nan van Geloven, PhD · Leiden University Medical Center, Netherlands

• Dacia Henriquez, MD, PhD · Amsterdam UMC, Netherlands

• Thomas van den Akker, MD, PhD · Leiden University Medical Center, Netherlands

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-05-01

Primary Completion

2021-01-01

Completion

2021-01-31

Countries

• Netherlands

Study Locations